BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSURE SP

    MDR report key: 4831500 · Received June 10, 2015

    Report

    Report Number
    2649622-2015-05520
    Event Type
    Injury
    Date Received
    June 10, 2015
    Date of Event
    April 4, 2015
    Report Date
    April 15, 2021
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P830061
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. CONCOMITANT PRODUCT: ADDR01 IPG, IMPLANTED: (B)(6) 2009. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A REMOTE MONITORING TRANSMISSION WAS SENT DUE TO PATIENT SYNCOPE. IT WAS NOTED THAT CAPTURE THRESHOLDS ON THE RIGHT VENTRICULAR (RV) LEAD MEASURED HIGH. IT APPEARED TO BE CHRONICALLY HIGH ACCORDING TO THE LEAD TRENDS. THE LEAD REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    377744 CAPSURE SP ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 4024-58

    Patients

    Seq Age Sex Outcome Treatment
    1 00066 YR Hospitalization| L| R 5076-52 LEAD| 5076-52 LEAD